Soft tissue repair system

ABSTRACT

A soft tissue repair system is provided for covering or filling openings in the annulus of an intervertebral disc. The soft tissue repair system uses a single plug or a combination of a first plug and a second plug. The second plug is a flowable plug such as an adhesive material or a material that hardens to a flexible plug material. Each plug is configured to close the opening in the annulus and can be positioned within the opening, over the opening at the exterior surface or over the opening at the interior surface. The plug can also be combined with a clamping mechanism that engages the annulus to secure the plug in the opening.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/105,153, filed May 11, 2011, which claims priority to U.S.Provisional Application Ser. No. 61/345,485 filed on May 17, 2010, whichare incorporated by reference herein in their entireties for allpurposes.

FIELD OF THE INVENTION

The present invention relates to soft tissue repair of the annulus ofintervertebral discs.

BACKGROUND OF THE INVENTION

The annulus of intervertebral discs is a soft fibrous tissue. This softtissue can develop defects or tears, and a portion of the nucleuspulposus can be squeezed through the tear causing pain and discomfort.In addition, the annulus is opened to provide access to the nucleuspulposus during discectomy procedures. The annulus remains open at thecompletion of the discectomy, leading to the possibility ofreherniation. A need to repair the tears or to close the openings in theannulus following surgical procedures exists.

Methods have been developed to repair tears and to close openings in theannulus. These methods include using sutures to close the tear, whichcan fail over time, and using plugs that are inserted into the tear.These plugs, however, are typically inserted from the exterior of theannulus and require difficult positioning or enlarging of the tear toaccommodate insertion of the plug. Some plugs only cover the externalside of the annulus tear. Therefore, improved systems and methods forannulus repair are desired.

SUMMARY OF THE INVENTION

Exemplary embodiments of the present invention are directed to methodsand systems for repairing annulus openings, i.e., tears, ruptures andholes in an annulus. In accordance with one exemplary embodiment, thepresent invention is directed to a soft tissue repair system thatincludes a first plug in combination with a second plug. Both plugs areconfigured to close an opening that passes through an annulus from anexterior surface of the annulus to an interior surface of the annulusand can be positioned in within the opening, over the opening at theexterior surface over the opening at the interior surface, or anycombination thereof. The second plug is separate from the first plug andis constructed of a flowable plug material.

In one embodiment, this flowable plug material is an adhesive material.In addition, the flowable plug material can set or harden to form aflexible plug material. In one embodiment, the first plug is a flexibleplug configured to conform to the contours of the annulus and theopening in the annulus. The first plug can also include a clampingmechanism to secure the first plug to the annulus. For example, theclamping mechanism can engage the interior surface and the exteriorsurface of the annulus adjacent the opening.

The locations of the first and second plugs with regard to the annulusopening can be varied. For example, the first plug can be disposedwithin the opening, and the second plug can act as a filler, beingdisposed between portions of the first plug and walls within theopening. Alternatively, the first plug can be disposed within theopening, and the second plug used to cover opening at the interiorsurface or exterior surface of the annulus. In one embodiment, the firstplug is a cover-type plug configured to cover the opening at theinterior surface or exterior surface of the annulus. In this embodiment,the second plug can be disposed within the opening.

In one embodiment, the first plug is arranged as an inflatable balloonhaving an inflated position configured to fill the opening in theannulus. The second plug is disposed within the first plug when thefirst plug is in the inflated position. In another embodiment, the firstplug is a collapsible cage having a pair of opposing ends and aplurality of arms extending between the opposing ends and fixedlysecured thereto. This collapsible cage is configured to collapse and toexpand to fill the opening in the annulus. The second plug is disposedwithin the opposing ends and the plurality of arms of the collapsiblecase and emerges from the collapsible cage as it is collapsed. In oneembodiment, each arm includes a spike disposed along its length andextending outward from the collapsible cage. Each spike penetrates theannulus, for example within the annulus opening, when the collapsiblecage is collapsed.

In one embodiment, the first plug includes a head portion configured tobe larger than the opening at the exterior surface of the annulus and atapered body attached to and extending from the head. The tapered bodynarrows as it extends from the head. The first plug also includes acentral cylindrical shaft extending completely through the head and thetapered body. The second plug is disposed in the central cylindricalshaft. In this embodiment, the first plug further also includes a pushrod that extends through the central cylindrical shaft. The push rod isconfigured to expel the second plug from the cylindrical shaft. In oneembodiment, the first plug also includes a plurality of barbs attachedto and extending from the head portion.

Exemplary embodiments of the present invention are also direction to asoft tissue repair system configured as a plug having a recess and ahole in the recess. A screw extends through the hole in the cap androtatable in the hole without rotating the cap. The screw includes ahead located in the recess and threads on a distal end opposite thehead. The plug also includes spreading bar having two ends and athreaded opening disposed between the two ends. The screw threads areengaged in the threaded opening. A pair of opposing arms is providedsuch that each arm extends from the cap and contacts an end of thespreading bar. The plug is configured such that rotation of the screwdraws the spreading bar toward the cap and pushes the arms apart. In oneembodiment, each arm includes a plurality of barbs extending from thatarm.

Exemplary embodiments of the present invention are also directed to asoft tissue repair system containing a plug having an integratedanchoring mechanism. The plug includes a plurality of independent andseparate segmented arms arranged around a common axis to form acylindrical shaped plug having an enlarged head. Proximal ends of thesegmented arms yield the enlarged head having an overall diameter thatis larger than an opening in an annulus that is to be repaired. Eachsegmented arm includes a plurality of segments configured such thatadjacent segments can pivot with respect to each other about a pivot pincommon to the adjacent segment. The plug also includes a threaded setscrew running through a center of the cylindrical shape that is createdby the plurality of segmented arms. The threaded set screw is concentricwith the common axis of the segmented arms and engages at least onesegment in each segmented arm. The plug is configured such that rotationof the threaded set screw about the common axis draws each engagedsegment along the common axis, pivoting adjacent segments with respectto each other and expanding an end of the plug opposite the enlargedhead. In one embodiment, the plurality of segments in each segmented arminclude a primary segment having a proximal end that is enlarged andincludes a hook portion, a first intermediate segment pivotally attachedto one end of the primary segment opposite the proximal end, a secondintermediate segment pivotally attached to the first intermediatesegment and an end segment pivotally attached to the second intermediatesegment. The first intermediate segment is disposed between the primarysegment and the second intermediate segment, and the second intermediatesegment is disposed between the first intermediate segment and the endsegment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a representation of an embodiment of flowable plug materialbeing inserted into an opening in an annulus in accordance with thepresent invention;

FIG. 2 is a representation of the flowable plug material filling theannulus opening and a portion of the interior of the disc;

FIG. 3 is a representation of an embodiment of a flexible plug disposedin an annulus opening in accordance with the present invention;

FIG. 4 is a representation of the flexible plug of FIG. 3;

FIG. 5 is a schematic representation of an embodiment of an insertermechanism holding the flexible plug of FIG. 3;

FIG. 6 is a schematic representation of the inserter mechanism of FIG. 5inserting the flexible plug in an annulus opening;

FIG. 7 is a schematic representation of the inserter mechanism of FIG. 5following insertion of the flexible plug in the annulus opening;

FIG. 8 is a representation of another embodiment of a flexible plughaving a central hole in accordance with the present invention;

FIG. 9 is a representation of an embodiment of a flexible plug incombination with an embodiment of a flowable plug material disposed inan annulus opening;

FIG. 10 is a representation of another embodiment of a flexible plug incombination with an embodiment of a flowable plug material disposed inan annulus opening;

FIG. 11 is a representation of another embodiment of a plug disposed inan annulus opening in accordance with the present invention;

FIG. 12 is a view of an embodiment of the cap portion of the plug ofFIG. 11;

FIG. 13 is a perspective representation of another embodiment of aflexible plug in accordance with the present invention;

FIG. 14 is a schematic representation illustrating the insertion of theplug of FIG. 13 in an annulus opening;

FIG. 15 is a representation an another embodiment of a plug inaccordance with the present invention in a deflated position;

FIG. 16 is a representation of the plug of FIG. 15 in an inflatedposition;

FIG. 17 is a representation of another embodiment of a plug inaccordance with the present invention in a closed position;

FIG. 18 is a representation of the plug of FIG. 17 in a first openposition;

FIG. 19 is a representation of the plug of FIG. 17 in a second openposition;

FIG. 20 is a schematic representation of the plug of FIG. 17 in thesecond open position deployed in an annulus opening;

FIG. 21 is a representation of another embodiment of a plug inaccordance with the present invention in an initial position;

FIG. 22 is a representation of the plug of FIG. 21 in an expandedposition;

FIG. 23 is a representation of another embodiment of a flexible plugdisposed in a plug inserter in accordance with the present invention;

FIG. 24 is representation of the plug and plug inserter of FIG. 23 withthe plug in a bent position;

FIG. 25 is a schematic representation of the plug of FIG. 23 in the bentposition disposed in an annulus opening;

FIG. 26 is a representation of another embodiment of a flexible plug foruse in accordance with the present invention;

FIG. 27 is a schematic representation of the plug of FIG. 26 insertedinto an annulus opening;

FIG. 28 is a schematic representation of the plug of FIG. 26 insertedinto an annulus opening and sutured to the annulus;

FIG. 29 is a representation of another embodiment of a flexible plug inaccordance with the present invention;

FIG. 30 is a schematic representation of the plug of FIG. 29 disposed inan annulus opening;

FIG. 31 is a schematic representation of another embodiment of aflexible plug disposed in an annulus opening and sutured to the annulus;

FIG. 32 is a representation of an embodiment of a cover-type plug inaccordance with the present invention;

FIG. 33 is a representation of another embodiment of a cover-type plugin accordance with the present invention;

FIG. 34 is a representation of another embodiment of a cover-type plugin accordance with the present invention;

FIG. 35 is a representation of another embodiment of a flexible plug inaccordance with the present invention;

FIG. 36 is a schematic representation of the flexible plug of FIG. 35disposed in a cannula for insertion into the annulus opening;

FIG. 37 is a schematic representation of the flexible plug of FIG. 35disposed in the cannula and partially inserted into the annulus opening;

FIG. 38 is a schematic representation of the flexible plug of FIG. 35and the cannula following insertion into the annulus opening;

FIG. 39 is a representation of another embodiment of a flexible plug andan anchor plate in accordance with the present invention;

FIG. 40 is a schematic representation of the plug and anchor plate ofFIG. 39 disposed in an annulus opening;

FIG. 41 is a representation of an embodiment of a plate for use withembodiments of plugs in accordance with the present invention;

FIG. 42 is a representation of the plate of FIG. 41 in combination withan embodiment of a flexible plug;

FIG. 43 is a representation of a side view of the flexible plug andplate of FIG. 42;

FIG. 44a is a schematic representation of another embodiment of acover-type plug in accordance with the present invention in a foldedposition;

FIG. 44b is a schematic representation of the cover-type plug of FIG.44a in an unfolded position;

FIG. 45a is a schematic representation of another embodiment of acover-type plug in a folded position in combination with the cover-typeplug of FIG. 44 a;

FIG. 45b is a schematic representation of the combination of cover-typeplugs of FIG. 45a with both plugs in an unfolded position;

FIG. 46 is a representation of another embodiment of a plug inaccordance with the present invention;

FIG. 47 is a representation of the plug of FIG. 46 with an embodiment ofan inserter rod and cannula;

FIG. 48 is the representation of the plug, inserter rod and cannula ofFIG. 47 with the inserter rod attached to the plug;

FIG. 49 is a representation of another embodiment of a flexible plugdisposed within a cannula in accordance with the present invention;

FIG. 50 is a representation of the flexible plug of FIG. 49 deployed outfrom the cannula;

FIG. 51 is a representation of another embodiment of a plug inaccordance with the present invention in an initial position forinsertion into an annulus opening;

FIG. 52 is a representation of the plug of FIG. 51 in a second positionfor retention within the annulus opening;

FIG. 53 is a representation of the plug of FIG. 51 disposed in anannulus opening as viewed from the exterior surface of the annulus;

FIG. 54 is a view through line 54-54 of FIG. 53;

FIG. 55 is a representation of another embodiment of a plug with aclamping mechanism in accordance with the present invention in aninitial position for insertion in an annulus opening;

FIG. 56 is a schematic representation of the plug with clampingmechanism of FIG. 55 disposed in the annulus opening in a clampedposition;

FIG. 57 is a representation of the plug with clamping mechanism in aclamped position as viewed from an interior of the annulus;

FIG. 58 is a representation of another embodiment of a plug with aclamping mechanism in accordance with the present invention in aninitial position for insertion in an annulus opening;

FIG. 59 is a schematic representation of the plug with clampingmechanism of FIG. 58 disposed in the annulus opening in a clampedposition;

FIG. 60 is a representation of another embodiment of a flexible plug inaccordance with the present invention in an initial position forinsertion in an annulus opening;

FIG. 61 is a representation of the plug of FIG. 60 in a second deployedposition for retention in the annulus opening;

FIG. 62 is a representation an another embodiment of a plug withclamping mechanism and anchor barbs in accordance with the presentinvention;

FIG. 63 is a representation of another embodiment of a plug as acollapsible cage in accordance with the present invention;

FIG. 64 is a representation of the plug of FIG. 63 in combination withan embodiment of a flowable plug material;

FIG. 65 is a representation of the plug and flowable plug material ofFIG. 64 in a collapsed position;

FIG. 66 is a representation of another embodiment of a plug andanchoring mechanism in accordance with the present invention;

FIG. 67 is a representation of the plug and anchoring mechanism of FIG.66 is a partially expanded position;

FIG. 68 is a representation of the plug and anchoring mechanism of FIG.66 in a fully expanded position and disposed in an annulus opening;

FIG. 69 is a representation of the plug and anchoring mechanism of FIG.66 in an expanded position as viewed from an interior of an annulus;

FIG. 70 is a representation of another embodiment of a plug andanchoring mechanism in combination with a flowable plug material anddisposed in an annulus opening in accordance with the present invention;

FIG. 71 is a representation of another embodiment of a cover-type plugin an expanded position in accordance with the present invention;

FIG. 72 is a representation of the cover-type plug of FIG. 71 in apartially folded position;

FIG. 73 is a representation of the cover-type plug of FIG. 71 in apartially fully position;

FIG. 74 is a representation of the cover-type plug of FIG. 71 folded,rolled and attached to an insertion mechanism;

FIG. 75 is a representation of the cover-type plug of FIG. 71 expanded,inserted into the interior of an annulus and anchored to the annulususing sutures;

FIG. 76 is a representation of an embodiment of a dart to be used inanchoring the cover-type plug of FIG. 71 into an annulus;

FIG. 77 is a representation of another embodiment of a plug withflowable plug material in a portion to be inserted into an annulusopening;

FIG. 78 is a representation of the plug of FIG. 77 disposed in anannulus opening with the flowable plug material expelled from the plug;

FIG. 79 is a schematic representation illustrating insertion of acover-type plug into the interior of a disc;

FIG. 80 is a representation of another embodiment of a cover-type plugin a coiled position for insertion into an annulus;

FIG. 81 is a representation of another embodiment of a cover-type plugapplied over an annulus opening;

FIG. 82 is a representation of the side view of the cover-type plugshown in FIG. 81;

FIG. 83 is a representation of another embodiment of a plug disposed ina cannula:

FIG. 84 is a representation of the plug of FIG. 83 disposed in anannulus opening;

FIG. 85 is a representation of another embodiment of a plug incombination with a clamping mechanism in accordance with the presentinvention;

FIG. 86 is a representation of one of the segmented arms of the plug ofFIG. 85;

FIG. 87 is a representation of the plug of FIG. 85 inserted into anannulus opening as viewed from the interior of the annulus;

FIG. 88 is a representation of the plug of FIG. 85 inserted into anannulus and moved to an expanded position as viewed from the interior ofthe annulus;

FIG. 89 is a representation of another embodiment of a cover-type plugdeployed over the exterior surface of an annulus;

FIG. 90 is a representation of the cover-type plug of FIG. 89 retractedinto a cannula;

FIG. 91 is a representation of another embodiment of a plug in anexpanded state;

FIG. 92 is a representation from the side of the plug of FIG. 91;

FIG. 93 is a representation of an embodiment of an anchor plate for usein an embodiment of a plug;

FIG. 94 is another representation of the anchor plate of FIG. 93;

FIG. 95 is a representation of another embodiment for the shape of theholes in the anchor plate of FIG. 93;

FIG. 96 is a representation of the plug and anchor plate embodiment ofFIG. 93 with the plug partially inserted into the anchor plate;

FIG. 97 is a representation of the plug and anchor plate embodiment ofFIG. 93 disposed in an annulus opening with the plug partially fullyinto the anchor plate;

FIG. 98 is a representation of another embodiment of an anchor plate foruse in an embodiment of a plug;

FIG. 99 is a representation of the plug and anchor plate embodiment ofFIG. 98 disposed in an annulus opening with the plug partially fullyinto the anchor plate;

FIG. 100 is a representation of another embodiment of a plug in apartially folded position in accordance with the present invention;

FIG. 101 is a representation of the plug of FIG. 100 in a fully foldedposition disposed in an annulus opening;

FIG. 102 is a representation of another embodiment of a plug inaccordance with the present invention;

FIG. 103 is a representation of another embodiment of a plug withclamping mechanism in accordance with the present invention;

FIG. 104 is a representation of the plug and clamping mechanism of FIG.103 disposed in an annulus opening with the clamping mechanism engaged;

FIG. 105 is a representation of another embodiment of a plug withclamping mechanism in accordance with the present invention;

FIG. 106 is a representation of the plug and clamping mechanism of FIG.105 with the clamping mechanism partially expanded;

FIG. 107 is a representation of the plug and clamping mechanism of FIG.105 with the clamping mechanism fully expanded;

FIG. 108 is a representation of another embodiment of a plug with aninserter tool inserted through an annulus opening;

FIG. 109 is a representation of the plug of FIG. 108 with curved needlespartially extended from the inserter tool;

FIG. 110 is a representation of the plug of FIG. 108 with curved needlesfurther partially extended from the inserter tool through the annulus;

FIG. 111 is a representation of the plug of FIG. 108 with curved needlesfurther partially extended from the inserter tool through the annulusand into a grip tool exposing sutures;

FIG. 112 is a representation of the plug of FIG. 108 with curved needlesin a grip tool that is partially withdrawn drawing sutures through theannulus and exposing the plug; and

FIG. 113 is a representation of the plug of FIG. 108 with the insertertool and grip tool withdrawn leaving the plug in the annulus opening andthe sutures secured at the exterior of the annulus.

DETAILED DESCRIPTION

Exemplary embodiments of products, e.g., implants and plugs, and methodsin accordance with the present invention repair and fill openings in theannulus of intervertebral discs that range from small fissures to largeropenings of approximately 6 mm. In addition to blocking or filling theopening, implants such as plugs that are inserted into the opening orcover-type plugs that are placed over the opening are secure and canwithstand internal disc pressures and accommodate the range of motion ofthe disc. The plugs can be inserted using minimally invasive surgicaltechniques. Suitable materials for the implants provide a desired amountof cushioning between adjacent vertebrae, sufficient flexibility andsufficient strength to close the opening and withstand disc movement andpressure. These materials include, but are not limited to, collagen,polymers such as polycarbonate urethane (PCU), elastomers and metalssuch as titanium. In one embodiment, the materials are resorbablematerials.

Soft tissue repair systems in accordance with the present inventionutilize a variety of structures and techniques to close openings in theannulus. These structures include, but are not limited to, plugs thatare inserted through and fixed within the opening, clamps or cover-typeplugs that cover the opening and are secured to the annulus or theopening, combinations of plugs and cover-type plugs and other devices.

Referring initially to FIGS. 1 and 2, an embodiment of a soft tissuerepair system in accordance with the present invention is illustrated.This embodiment uses a plug to fill the opening. In this embodiment, theplug is formed from a flowable or formable material that can be insertedinto an opening in the annulus and that can fill the shape of theannulus and any voids in the nucleus pulposus. The flowable materialthen sets or cures to a flexible material than can retain its assumedshape.

The annulus 100 has an opening 110 passing completely through theannulus and exposing the nucleus pulposus 125. This opening, or anyannulus opening as disclosed herein, can result from a tear in theannulus 100 or a passage cut into the annulus 100 during a surgicalprocedure. A hollow and expandable insertion or injection tool orcannula 120 is inserted through the opening 110 and into the nucleuspulposus 125. In one embodiment, a portion 135 of the nucleus pulposusis removed by discectomy. In accordance with all embodiments herein thatuse an injection tool or cannula, the injection tool 120 can be dilatedto expand the opening 110. An adhesive material 130, i.e., the flowableplug material, is passed through the hollow core of the injection tool120 and into the portion 135 of the nucleus pulposus 125. As theinjection tool 120 is withdrawn from the opening 110, the adhesivematerial 130 fills the opening. A large portion 140 of the adhesivematerial remains within the interior of the annulus 100 to aid inretaining the plug in the annulus 100 and to fill the vacated portion135 of the nucleus pulposus 125. Therefore, the plug will not migrateinward or outward through the opening. Suitable adhesive materialsinclude silicone adhesives and resorbable silicone adhesives.

Referring to FIGS. 3-7, another embodiment of a soft tissue repairsystem utilizing a plug is illustrated. In this embodiment, the plug 220is formed from a soft, rubbery flexible material. The plug 220 includesa stem or plug portion 260 and an opposing pair of wing portions 240.The plug 220 has a natural or resting position as shown in FIG. 4 and isof sufficient flexibility and resiliency that the opposing pair of wingportions 240 can be bent to fit through an opening 205 in the annulus200 and return to the natural position within the nucleus pulposus 210.In one embodiment, the wing portions 240 have a curvature in the naturalposition that matches the curvature of the interior of the annulus 200.

When the wing portions 240 return to their natural positions within thenucleus pulposus 210, intradiscal pressure on the wing portions 240holds the plug 200 in position. In addition, the stem portion 260 holdsthe plug 220 in position by providing pressure against the sides of theopening 205. Using the stem portion 260 to hold the plug 220 in theopening 205 is enhanced by forming the stem portion 260 with a wedgeshape such that the larger or fatter portion of the wedge is disposed inthe opening 205 adjacent the outside of the annulus 200.

In order to insert the plug 220 into the opening 205 of the annulus 200,an injector or cannula 280 (FIG. 5) is used. The injector 280 includes ahollow outer tube 285 that has an outer diameter 225 that is selected toaccommodate the size of the opening 205. In one embodiment, the outerdiameter 225 is selected so that the outer tube 285 can pass into theopening 205. The outer tube 208 also has an inner diameter 245 that isselected to accommodate the plug 220 and to bend or compress the wingportions 240 of the plug 220 to a size that will pass through theopening 205 in the annulus 200. The injector 280 also includes aclamping mechanism 290 running through the inner diameter 245 of theouter tube 285. The clamping mechanism 290 holds the stem portion 260 ofthe plug 220. A handle portion 295 is attached to the clamping mechanism290. The handle portion 295 can move the clamping mechanism 290 throughthe hollow outer tube 285 and can actuate the clamping mechanism 290 togrip or to release the plug 220. In one embodiment, the clampingmechanism 290 is formed from a pair of opposing, spring-loaded arms. Asthe arms are drawn into the outer tube by the handle portion, the armsare pulled together, clamping the stem of the plug between them. As thearms are pushed out from the outer tube, the arms move away from eachother under the spring-loaded force, releasing the stem of the plug.

In use, the handle portion 295 pushes the clamping mechanism 290 outfrom the inner diameter 245 of the outer tube 285, and the stem portion260 of the plug 220 is placed within the clamping mechanism 290. Thehandle portion 295 then draws the clamping mechanism 290 into the outertube 285, which pulls the plug 220 into the inner diameter 245,deforming the wing portions 240 (FIG. 5). The injector 280 is thenbrought adjacent the opening 205 of the annulus 200, and the handleportion 295 advances the clamping mechanism 290 and the plug 220 outfrom the outer tube 285 (FIG. 6). As the plug is advanced, the wingportions 240 pass within the opening 205 so that the opening preventsthe wing portions 240 from returning to their natural position. Once thewing portions 240 pass sufficiently through the opening 205, they expandin the nucleus pulposus 210 to their natural state, contacting andsecuring the plug 220 in the opening 205 (FIG. 7). The clampingmechanism 290 releases the stem portion 260 of the plug 220, and theinjector 285 is removed.

Although a plug alone sufficiently repairs and seals annulus openings,the size and shape of annulus openings vary creating mismatches and gapsbetween the plug and the opening. In addition, the curvature of theinternal or winged portions of the plug may not exactly match or mirrorthe interior shape of the annulus. In one embodiment of the soft tissuerepair system of the present invention, a first flexible plug is used inconjunction with a second flowable plug material to compensate for thegaps or mismatches between the annulus opening and the flexible plug.The flowable plug material, for example as described above, can be usedin combination with any of the plug embodiments described herein,including flexible plugs and cover-type plugs or clamps.

In one embodiment, the second flowable plug material is inserted throughthe first plug such that the flowable plug material is located betweenthe first plug and the nucleus pulposus. Referring to FIG. 8, any givenplug 300, for example a first flexible plug, can include a hole orchannel 310 that runs completely through that plug. This hole 310accommodates a hollow tube 320. The hollow tube 320 functions as aconduit to inject flowable plug material through the flexible plug 300.As shown in FIG. 9, an embodiment of a first flexible plug 335 isinserted into an opening 355 in an annulus 330. The second flowable plugmaterial, for example adhesive material, is passed through a centralhole 385 in the flexible plug so that a portion 340 of the flowable plugmaterial is disposed inside the annulus 330 adjacent the flexible plug335. The flowable plug material also fills the central hole and isdisposed in any spaces between the flexible plug and the opening 355. Aportion 350 of the flowable plug material seals the outside of theopening 355.

Referring to FIG. 10, the first flexible plug 225 is inserted in anotheropening 365 in an annulus 360, and the second flowable plug material ispassed through the central hole 385 in the opening so that a portion 375of the flowable plug material completely fills a cavity 370 in thenucleus pulposus 380. The flowable plug material also fills the centralhole and is disposed in any spaces between the flexible plug and theopening 365. A portion 390 of the flowable plug material seals theoutside of the opening 365. In either embodiment, the flowable plugmaterial sets or hardens over time to form a second flexible plugmaterial.

Referring to FIGS. 11-12, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. The plug420 includes a cap 435 and a screw 440 extending through a hole 425 inthe cap 435. The screw 440 is free to rotate about its long axis withoutrotating the cap 435. The proximal end of the screw 440 includes a head470 that is located in a recess 430 of the cap 435. Therefore, the head470 of the screw 440 does not extend beyond the cap 435. The head 470 islarger in diameter than the hole 425 and includes a slot 465 (FIG. 12)to accept a tool for turning the screw 470. In one embodiment, the slot465 is a hexagonal slot. Suitable materials for the cap 435 and screw440 include, but are not limited to titanium and polyether ether ketone(PEEK). In one embodiment, the screw 440 is titanium and the cap 435 isPEEK.

The distal end of the screw includes threads 445. The threads 445 passthrough a threaded opening 415 in a spreading bar 450 of the plug 420.Suitable materials for the spreading bar include, but are not limited totitanium, PEEK, polycarbonate-urethane (PCU) and combinations thereof.For example, the portion of the spreading bar 450 containing thethreaded opening 415 is constructed of titanium, and the body of thespreading bar 450 including all bearing surfaces is PEEK or PCU. Theplug also includes are least one pair of opposing arms 455. Each arm 455includes a plurality of barbs or tangs 460. The opposing arms 455 are incontact with the cap 435 and with opposite ends of the spreading bar450. Additional opposing pairs of arms can be included. The plug 420 isinserted in the direction of arrow A through an opening 410 in theannulus 400. The screw 440 is rotated in the direction of arrow B,pulling the spreading bar 450 in the direction of arrow C and spreadingthe opposing arms 455 in the directions indicated by arrow D. Thisimpinges the opposing arms 455 on the walls of the opening, driving thetangs 460 into the annulus and anchoring the plug 420 in the opening410. In one embodiment, the cap 435 is of sufficient size to completelyclose the opening, and the cap 435 is positioned flush with the exteriorsurface 475 of the annulus 400. As with all plugs described herein, thisfirst plug can be used in combination with a second flowable plugmaterial to compensate for any gaps between the opening 410 and the plug420.

Referring to FIGS. 13 and 14, another embodiment of the soft tissuerepair system of the present invention using a plug is illustrated. Thisembodiment utilizes a plug 500 having a conical main body 505 that isconstructed from a load bearing compliant material that mimics the loadbearing properties of the annulus 545. The plug 500 also includes a pairof opposing flexible wings 510. In one embodiment, the flexible wings510 are constructed from the same material as the main body 505. In thisembodiment, the main body 505 and flexible wings 510 can be molded as asingle unit. Alternatively, the wings 510 are constructed from amaterial or fabric that can be sutured to the annulus 545. In thisembodiment, the flexible wings 510 are formed separate from the mainbody 505 and are subsequently attached to the main body 505. In oneembodiment, the plug 500 includes a plurality of pairs of opposingflexible wings. In another embodiment, the plug 500, in place ofopposing flexible wings, includes a ring or flange of flexible materialattached to one end of the main body 505.

The flexible wings have a natural or resting position 515 and can beflexed or bent between a first position 520 adjacent the main body 505and a second position 525. The plug 500 also includes a central hole 530that passes completely through the main body 505. The hole facilitatesattachment of an inserter 540 to grip the plug 500 during insertion andintroduction of a flowable plug material through the main body 500 andinto the interior of the annulus 545. The opposing flexible wings 510can be attached to either the larger or smaller end of theconical-shaped main body 505.

In order to insert the plug 500 into the opening 550 of the annulus 545,an inserter 540 is attached to the plug 500, and the plug is pushedthrough the central bore of a cannula or endoscope 535 bending theflexible wings 510 into the second position 525. The smaller diameterside 565 of the main body 505 is presented to the opening 550 first. Theplug can be inserted to a first position 555 where the main body isdisposed in the opening 550 and the flexible wings are in contact withthe exterior surface 570 of the annulus 545 or a second position 560where the main body 500 is passed completely through the opening 550 andthe flexible wings are in contact with the interior surface 575 of theannulus 545. In either the first position 555 or the second position560, sutures (not shown) can be used to secure the flexible wings to theannulus. In addition, this plug 500 can be used in combination with theflexible plug material. The plug blocks the pressure from the nucleuspulposus and bears loads acting on the spine.

Referring to FIGS. 15 and 16, another embodiment of the soft tissuerepair system of the present invention using a plug is illustrated. Inthis embodiment, the plug 580 is an inflatable balloon constructed froma material that can be inflated or stretched to fill an opening in anannulus. The plug can maintain this inflated position under the pressureof a fill gas or flowable material or can set or harden in the inflatedposition, obviating the need to maintain a pressurized fill gas orflowable fill material within plug. The inflatable balloon plug 580includes a balloon portion 585 made from a polymeric material and one ormore flexible wings 590 attached to one end of the balloon portion 585.The flexible wings can engage the exterior or interior surface of theannulus adjacent the opening on the annulus. A filler tube 595 is alsoprovided in communication with the balloon for communicating filler orinflating material, e.g., gas or flowable plug material, into theballoon. Although illustrated as a uniform circular or oblong balloon,the balloon portion 585 can be constructed with a non-uniform shape andcan include bulging sections that will inflate to larger sizes and thatcan be positioned on the interior or exterior of the annulus to hold theplug in place.

The plug 580 is inserted into an opening in the annulus with the balloonportion 585 in a deflated state (FIG. 15). The balloon portion is theninflated (FIG. 16). Inflation can be initiated using a pressurized gassuch as an inert gas passed through the filler tube 595. Following gasexpansion or separately as an alternative to gas expansion, a polymericmaterial, i.e., a flowable plug material, is introduced through thefiller tube 595 into the interior of the balloon section 585. In oneembodiment, the balloon section 585 is inflated and filled withelastomeric sheath. Once inflated, the balloon section 585 fills andseals the opening in the annulus, conforming to the shape of the wallsof the opening. The filler tube is then removed.

Referring to FIGS. 17-20, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 600 utilizes an umbrella mechanism. The plug 600includes a plug portion 605 formed with a plurality of flexible rods610. Each flexible rod 610 has one end attached to a pivot point 625.Suitable materials for the flexible rods 610 include titanium andpolymers. A thick compliant and foldable sheet of material 611 isattached to and covers the flexible rods 610. Suitable materials for thesheet of material 611 include, but are not limited to, polymers andpolymeric sheath. The sheet of material forms folds or pleats 615between the flexible rods 610. An inserter and actuator 620 is removablyattached to the pivot point 625. In one embodiment, the inserter andactuator 620 is attached to the pivot point 625 with a threadedattachment. The actuator 620 can move the plug portion 605 from a closedinsertion position (FIG. 17) to either a first open position (FIG. 18)or a second inverted open position (FIG. 19). The selected open positionis based on the shape of the annulus adjacent the opening, i.e., concaveor convex.

To insert the plug 600 into an opening 640 in an annulus 635, theinserter 620 is attached to the pivot point 625 of the plug portion 605,and the plug 660 in the closed position is passed through a cannula 630pivot point 625 first. The plug portion 605 is passed completely throughthe opening 640, and the inserter 620 moves the plug portion to thesecond inverted open position within the annulus 635. The sheet ofmaterial 611 is secured to the annulus 635 using sutures (not shown).The inserter 620 is unscrewed and removed. In one embodiment, a secondflowable plug material is used to fill the opening and to fill the plugportion.

Referring to FIGS. 21-22, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 650 a compliant sheet 655 arranged as a tube orsock. Suitable materials for the compliant sheet 655 include, but arenot limited to, polymeric sheath. The plug 650 includes a firstcylindrical collar 660 and a second cylindrical collar 670. The collarsare constructed of a stiff elastomeric material, and the first collar660 has a diameter 676 that is larger than the second collar 670 suchthat the second collar 670 fits inside the first collar 660. In oneembodiment, each collar has a length that is less than the thickness ofthe annulus opening to be repaired. A first end 680 of the compliantsheet 655 is attached to the first collar 660, and a second end 685 ofthe compliant sheet 655 is attached to the second collar 670. Since thecompliant sheet 655 is arranged as a tube or sock, the compliant sheet655 is attached around the entire outer diameter of each collar. In oneembodiment, the compliant sheet 655 is attached to the first collar 660such that in an initial state (FIG. 21) the first collar 660 is locatedoutside the compliant sheet 655, and the compliant sheet is attached tothe second collar 670 such that in the initial state the second collar670 is located inside the compliant sheet.

The plug 650 also includes an inserter rod 681 that runs through thesecond collar 670, the tubular compliant sheet 655 and the first collar660 and is releasably attached inside the first collar 660 at an end 675opposite to where the compliant sheet 655 is attached to the firstcollar 660. The inserter rod 681 can be releasably attached to the usinga threaded connection or a frangible connection. In one embodiment, theinserter rod 681 is hollow and the end 675 of the first collar 660 hasan opening such that a flowable plug material can be passed through theinserter rod 681 and first collar 660.

The plug 650, in the initial state, is inserted into an opening in anannulus. The inserter rod is moved in the direction of arrow E (FIG. 22)until the second collar 670 is disposed inside the first collar 660, andthe plug 650 is in the expanded state. In one embodiment, the first andsecond collars lock into this nested state, for example using a pressurefit between the two collars, interlocking tangs, ratcheted closermechanisms or any other suitable mechanism. In the expanded state, thecompliant sheet 655 gathers together and expands in size, filling theopening of the annulus. In one embodiment, the interior 682 of thecompliant sheet 655 is not filled. Alternatively, the interior 682 ofthe compliant sheet 655 is filled with a flowable plug material. Afterthe plug 650 is placed in the expanded position, the inserter rod 681 isremoved. In one embodiment, the compliant material is sutured to theannulus.

Referring to FIGS. 23-25, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 700 has a cylindrical or rod shape and isconstructed of a flexible and resilient material. In one embodiment, thematerial is PCU. In one embodiment, the plug has a circular, oval,square or rectangular cross-section, although other cross-sectionalgeometries are also possible. The plug 700 is passed through a slot 715in an inserter rod 710. Suitable materials for the inserter rod 710include, but are not limited to, titanium and polymers. The slot 715 issized to accept the plug 700 and to hold the plug securely when the plugis inserted into an opening 730 in an annulus 720. In addition, the slot715 includes a top edge 716 formed or sharpened to cut through the plug700. As show in FIG. 24, when the inserter rod 710 is moved in thedirection of arrow F through an opening, the plug 700 on either side ofthe inserter rod 710 will bend in the direction of arrows G.

Referring to FIG. 25, the inserter rod 710 holding the plug 700 ispassed through the opening 730 in the annulus 720 until the entire plug700 is located in the interior 725 of the annulus 720. The inserter rod710 is sized to move freely through the opening. The plug 700 is sizedto fit tightly within the opening. As the inserter rod 710 is pulledback through the opening 730 in the direction of arrow H, the plug 700doubles over, bending in the direction opposite to arrow H. The bentplug 700 passes back through the opening 730, becoming logged in theopening 730. Continuing to pull the inserter rod 710 slices through theplug 700, forming two pieces of plug and freeing the inserter rod 710.The two pieces of plug remain in the opening, and any portion of the twopieces that extends beyond the outer edge 721 of the annulus 720 is cutoff and removed. Alternatively, the inserter rod slices through thedoubled over plug as the plug and rod are initially inserted through theannulus opening. The freed inserter rod is then pulled back through theannulus opening. A second flowable plug material can also be introducedinto the opening around the two plug pieces, or the plug can be dippedinto or coated with a second flowable plug material prior to insertionin the opening.

Referring to FIGS. 26-28, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 750 includes a base 751 having a disc shape, a stem752 extending from the base and an anchoring structure 753 extendingfrom an end of the stem 752 opposite the base 751. In one embodiment,the disc-shaped base 751 has a diameter 757 that is greater than thesize of the opening 763 in the annulus 758 that is to be repaired. Inone embodiment, the anchoring structure 753 includes at least two oralternatively a plurality of arms 754 arranged as diametrically opposedpairs and extending out from the stem 752 and back along the stem 752toward the base 751. The arms 754 extend out from the stem 752 adistance 755 that is greater than the size of the opening 763 in theannulus 758 that is to be repaired by the plug 750. The arms 754 areflexible and can bend toward the stem 752. In addition to being formedas a plurality of independent arms, the anchoring structure 753 can beformed as a continuous flange of material that extends back toward thebase and away from the stem to form a cone. In one embodiment, the base751, stem 752 and anchoring structure 753 are molded as a single unitarystructure. Suitable materials for the plug 750 include, but are notlimited to, PCU.

The anchoring structure 753 forms a wedge shape to facilitate insertionof the plug 750 through the opening 763 in the annulus 758. In addition,the arms 754 of the anchoring structure 753 flex or compress to easeinsertion through the opening 763. The plug 750 is inserted through theopening 763 until the anchoring structure 753 is completely disposedwithin the interior 759 of the annulus 758. The arms 754 can then returnor expand to their natural or resting position. In this position, thearms 754 engage the interior surface 760 of the annulus 758. The stem752 is formed of a length such that the distance 756 between theanchoring system 753 and the base 751 allows the anchoring system 753 toengage the interior surface 760 of the annulus 758 while the base 751engages the exterior surface 761 of the annulus 758. In one embodiment,this distance 756 is selected to be slightly less than the thickness ofthe annulus 758 or depth of the opening 763 to provide a slight pressureor force in opposite directions on the base 751 and the anchoring system753. This assists in holding the plug 750 in the opening 763. Referringto FIG. 28, in one embodiment, sutures 762 are placed through the base751 and annulus 758 to further anchor the plug 750 in the opening 763.In one embodiment, the plug 750 is used in combination with a secondflowable plug material. For example, at least one of the anchoringstructure 753 and a stem 752 is coated with or covered with a cap offlowable plug material. As the plug 750 is inserted into the opening,the flowable plug material conforms to the shape of the interiorcontours of the opening.

Referring to FIGS. 29-30, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 770 is a single block of flexible material.Suitable flexible materials include, but are not limited to, fabric,woven material, PCU and/or collagen. The material may be soaked intissue growth promoting agents. The plug 770 has an elongated shape, andthe cross section of the plug 770 can be any desired geometric shapeincluding, circular, square, rectangular or square. In one embodiment,the plug 770 is formed or molded into the desired shape and length andthen is inserted into an appropriate opening in an annulus. The openingin the annulus can be cut to the appropriate size and shaped for theplug. Alternatively, the plug 770 is formed as a standard sized block ofmaterial that is custom cut or fitted prior to insertion. Therefore, theplug 770 is custom fit to the size and shape of the opening 771 in theannulus 772 (FIG. 30), taking into account, for example, a narrowing ofthe opening 711 as the plug extends towards the interior 773 of theannulus 772. In addition, the plug can be trimmed following insertioninto the opening 771, for example to be flush or level with the exteriorsurface 774 of the annulus 772. In one embodiment, the plug 770 isconstructed of a material that has cushioning and support propertiesthat mimic those properties from the annulus 772. This plug can also beused in conjunction with the second flowable plug material to fill gapsbetween the plug 770 and the opening 771 and to assist in anchoring orsecuring the plug 770 in the opening.

Referring to FIG. 31, in another embodiment, the plug 780 formed from aflexible material is cut to conform to the size and shape of the opening781 in the annulus 782 and to fill the opening completely. A pluralityof stitching elements or sutures 784 are used on the exterior surface783 of the annulus 782 to secure the plug 780 in the opening 781.Although these plugs have been shown as being inserted into andsubstantially filling the opening, other plugs can be used that attachto the exterior surface of an annulus and close the opening withoutextending into the opening. In one embodiment, a cap of covering typeplug 790 (FIG. 32) is illustrated that has a rectangular shape thatcovers an opening and extends around a portion of the exterior of theannulus. This plug 790 also includes a plurality of tangs or prongs 791extending from one side. These prongs 791 are pressed into the annulusto hold the plug 790 in place. Other embodiments include a square captype plug 792 with a plurality of prongs 793 (FIG. 33) and a circularcap type plug 794 with a plurality of prongs 795 (FIG. 34). Thesecap-type plugs can be used with other flexible plugs or a secondflowable plug material that fill the opening. In addition, sutures canalso be used to anchor the cap-type plugs to the annulus. Suitablematerials for the cap like plugs include, but are not limited to, PCU.The prongs can be made of titanium or polymers.

Referring to FIG. 35, the plug 800 is formed or cut from a flexiblematerial such as PCU or collagen. The plug has an elongated central body802 and a pair of opposing flexible extensions 804 on either end of thecentral body. The central body 802 has a length that is sufficientenough to extend through an opening in an annulus. The area of each endas defined by the flexible extensions 804 and the end of the centralbody 802 is larger than the opening in the annulus. In addition, theflexible extensions 804 can be sufficiently bent or deformed to fitthrough the opening in the annulus. In one embodiment, the natural orresting position of each extension 804 extends generally perpendicularto the long axis of the central body 802. The extensions 804 could alsoextend at an angle or be curved to accommodate the associated curvatureof the annulus.

Referring to FIGS. 36-38, the plug 800 is placed in the central bore 808of a cannula or endoscopic tool 806. The diameter 818 of the centralbore 808 is selected so that the extensions 804 have to bend to fit. Inone embodiment, the diameter 818 of the central bore is less than orsubstantially equal to the size 814 of the opening 812 in the annulus810. Therefore, the plug 800 can easily pass from the central bore 808through the opening 812, and the opening 812 holds the extensions 804 inthe folded position until the extensions pass the interior surface 816of the annulus 810. In another embodiment, the diameter 820 of thecannula is less than the size 814 of the central bore 808. Therefore,the cannula can be inserted fully through the opening 812 to theinterior surface 816 of the annulus 810, and the central bore 808 holdsthe extensions 804 in the folded position until the extensions pass theinterior surface 816 of the annulus 810. The opening 812 can be cut orformed to be of a desired size and shape to accept the plug 800 and thecannula 806.

The plug 800 is advanced through the central bore 808 in the directionof arrow I, and the cannula 806 is brought adjacent the annulus 810. Theplug 800 is pushed out from the central bore 808 until a leading pair ofextensions 824 emerge from the opening, return to their natural stateand engage an interior surface 816 of the annulus 810 (FIG. 37). Theseextensions 824, being made of flexible and resilient material, may bendslightly in accordance with the curvature of the interior surface 816.The cannula 806 is then pulled away from the annulus 810, pulling theplug 800 from the central bore 808. The trailing extensions 826, afteremerging from the central bore 808, return to their natural state andengage an exterior surface 822 of the annulus 810 (FIG. 38). Theseextensions 826, being made of flexible and resilient material, may bendslightly in accordance with the curvature of the interior surface 822.The length of the main body 802 is selected such that the leading andtrailing extensions remain in contact with the interior and exteriorsurfaces of the annulus, holding the plug in the desired position. Theextensions may also be stitched or sutured to the annulus, and a secondflowable plug material can also be used in combination with this plug800.

Referring to FIGS. 39-40, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a plug 840 is constructed of PCU or collagen Type I. Theplug preferably has a square profile with equal height 842 and width844. The depth 846 is selected based on the thickness of the opening 848in the annulus 850 that is to be repaired. In one embodiment, aplurality of plugs 840 is provided, each one having one of a pluralityof square dimensions, for example 2 mm×2 mm, 4 mm×4 mm, 6 mm×6 mm and 8mm×8 mm, among others. The specific size of the plug is selected basedon the width 852 of the opening 848. In one embodiment, the opening 848is cut to a known size that corresponds to one of the available sizes ofthe plug 840. In order to repair the opening 848, the appropriatelysized plug 840 is inserted into the opening 848.

Although the plug 840 can be sewn to the annulus 850 to secure it in theopening, preferably an interior patch or anchor 842 is used to anchorthe plug 840 in the opening 848. In one embodiment, the interior patch842 is formed from a resorbable material. The interior patch 842includes a pair of opposing arms 856, a stem portion 858 extendingperpendicularly from the opposing arms 856 and a collar 862 on an end ofthe stem portion 858 opposite the opposing arms. The distance betweenthe opposing arms 856 and collar 862 is set based on the depth 846 ofthe plug 840. The plug 840 includes a central hole 860 that is ofsufficient width 854 to accommodate the stem 858 of the interior patch842. The interior patch 842 is passed through the opening 848 in theannulus 850 until the opposing arms 856 are disposed in the interior ofthe annulus 850. The stem portion 858 extends back through the opening848, and the appropriately sized plug 840 is pushed over the collar 862,into the opening 848 and onto the stem 858. The collar includes abeveled leading edge 864 to assist in the insertion of the stem portion858 into the hole 860 in the plug 840. The force between the plug 840and the opening 848 in combination with the opposing arms 856 anchorsthe plug 840 in the opening 848. In one embodiment, the stem 858 issized larger than the size 854 of the hole 860 in the plug 840, causingthe plug 840 to expand slightly and increasing the frictional forcebetween the plug 840 and the opening 848. In addition, the plug 840 canbe stitched or sewn to the annulus. In one embodiment, this plug 840 isused in combination with a second flowable plug material, and theflowable plug material can be passed through a central opening 866 inthe stem 862 to the interior of the annulus 850.

Referring to FIGS. 41-43, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a plate 870, i.e., a cover-type plug, is used in combinationwith a plug 864. The plate can be used in combination with any of theplug embodiments described herein. As illustrated, an elongated plug 874having a generally rectangular cross-section is attached to one side ofthe plate 870. Alternatively, the plate can be independent of the plug,and the plug is inserted in the annulus opening separate from the plate.Suitable materials for the plate include titanium, elastomers andpolymers. In one embodiment, the plate 870 is a rectangular plate andincludes a plurality of holes 872 passing completely through the plate870. These holes accommodate fasteners such as titanium screws andpolymer screws. Although the plate can be attached to the annulus,preferably, the plate is secured by screws to the superior and inferiorvertebral body of the annulus being repaired. In order to accommodateattachment to the vertebral body, the plate 870 has a length 876 that issufficient to span the annulus and to extend sufficiently over thevertebral body. This prevents expulsion of the plug from the annulus.Therefore, the plug is placed in the annulus opening, and the plate,positioned over the plug, is fastened to the adjacent vertebral body.

Referring to FIGS. 44a, 44b, 45a and 45b , another embodiment of thesoft tissue repair system of the present invention using a plug isillustrated. In this embodiment, two cap-type or covering-type plugs areused to cover the interior and exterior of the opening in the annulus.The interior cap-type plug 880 includes a pair of opposing wings 884that can be bent or flexed so that the plug 880 can be passed through acannula and through the opening in the annulus. An inserter rod 882 isattached to the plug 880. Suitable attachment mechanisms include, butare not limited to frangible attachments and releasable attachments suchas threaded attachments. In one embodiment, the inserter rod 882 isfixedly and non-releasably attached to the plug 880. Once the plug 880is passed through an opening in the annulus and into the interior of theannulus, the wings 884 extend outward (FIG. 44b ), for example under theforce of their inherent resiliency, and engage an interior surface ofthe annulus. The wings 884 can also be forced open using a push rod orpush collar associated with the inserter rod 880.

An exterior cap-type plug 886 having a pair of opposing wings 888 isthen passed along the inserter rod 882 (FIG. 45a ). The exterior plug886 includes a center hole to accommodate the inserter rod 882. Theopposing wings 888 are bend forward toward the annulus. Therefore, asthe exterior plug 886 is brought into contact with the annulus, theopposing wings expand and contact the exterior surface of the annulus.Alternatively, the opposing wings 888 are held in the bent position by acannula and expand to a natural position under the force of theirinherent resiliency as they emerge from the cannula. Once both theinterior and exterior plugs are in position (FIG. 45b ), they sandwichthe annulus, closing both sides of the opening. Both plugs can be sewnto the annulus. In one embodiment, the inserter rod passes from theinterior plug 880 through the exterior plug 886, engaging the exteriorplug in a locking arrangement. Therefore, the inserter rod can beclipped at the exterior plug, and the remaining portion of the inserterrod holds the interior and exterior plugs together.

Referring to FIG. 46, an exemplary embodiment of a plug 890 that can beused as either an interior or exterior cap-type plug is illustrated. Theplug includes a main body 892 formed as a small sheet of an elastomericor polymeric material. In one embodiment, the main body 892 is formed ofa material that can be sewn to the annulus. In general, the material ofthe main body 892 has sufficient strength to prevent the nucleuspulposus from being expelled through the opening and to prevent plugmaterial within the opening from being expelled. The main body 892 is ofa sufficient size to completely cover the opening and can be any desiredshape including rectangular, square, circular, oblong or a custom shape.

At least one opposing pair of flexible resilient members 896 attached tothe main body 892 extend from a central support member 894 that is alsoattached to the main body 892. In one embodiment, the two resilientmembers 896 are mirror images of each other and extend in oppositedirections across the main body 892. In one embodiment, the pair ofresilient members 896 has a resting or natural position that holds themain body in a flat position. When a flexing force is applied to theresilient members, the resilient members bend, causing the main body tobend accordingly. However, the resilient members 896 return to theirnatural position when the flexing force is no longer applied. Suitablematerials for the resilient members 896 and the support member 894include, but are not limited to, metals such as titanium. In oneembodiment, a stem 898 extends from the support member 894 in adirection perpendicular to the support member 894 and the main body 892.The stem 898 is constructed from the same material as the main body 890.The stem 898 provides a point of attachment for an inserter rod and caninclude threads to provide a screw-type attachment. In anotherembodiment, the support member 894 includes a central hole in place ofthe stem. Therefore, an inserter rod can be passed through the centralhole.

Referring to FIGS. 47 and 48, and embodiment of the plug 890 isillustrated where the resilient members 896 have a resting or naturalposition that is curved. In addition, the support member 894 can have acorresponding curvature. The main body 892 follows the resting curvatureof the resilient members 896. An inserter rod 895 having a threaded end893 is provided inside a hollow tube or cannula 897. The inserter rod895 can move within the cannula 897. With the threaded end 893 of theinserter rod 895 extending from the cannula 897, the threaded end 893 isthreaded onto the stem 898. The inserter rod 895 can then be used toposition the plug 890 adjacent an annulus opening or to push the plug890 through the annulus opening. By pushing the cannula toward the plug890 and engaging the support member 894 and the resilient members 896with the cannula, the plug 890 is moved to a flat position (FIG. 48)that is used to engage either the interior or exterior surface of theannulus.

Referring to FIGS. 49-50, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, cap-type plugs are used in combination with a clampingmechanism such that the opening in the annulus is disposed or clampedbetween two cap-type plugs disposed on the interior and exterior of theannulus opening. The system of this embodiment includes a first cap-typeplug 902 having a pair of opposing, flexible and deployable wings 906.In one embodiment, the first cap-type plug 902 is fixed to a centralshaft 910. The system also includes a second cap-type plug 904 having apair of opposing, flexible and deployable wings 908. In one embodiment,the second cap-type plug 904 is attached to the central shaft 910 andcan slide along the central shaft 910. The opposing wings can also bearranged as a flexible flange or collar that extends completely aroundthe central shaft 910. A wire or thread 912 running through the centralshaft 910 is as attached to both of the opposing wings 906 of the firstplug 902. A cannula 914 is provided for deploying the system, and bothplugs and the central shaft are initially located within the cannula914. The opposing wings of both plugs are bent toward the central shaftin order to fit within the cannula. The thread 912 extends out from thecannula.

The central shaft is placed adjacent or inserted through an opening inan annulus, and the central shaft 910 and plugs are advanced through thecannula 914 until the first plug 902 emerges from the cannula 914 intothe interior of an annulus. The first plug 902 becomes the interiorplug. In one embodiment, the thread 912 is pulled to open the opposingwings 906. Alternatively, the opposing wings 906 spring to a natural orresting position that is generally perpendicular to the central shaft910 as they emerge from the cannula 914. The central shaft 914 andsecond plug 904 continue to advance from the cannula 914 until thesecond plug emerges from the cannula 914 adjacent the annulus opening onthe exterior of the annulus. The second plug 904 becomes the exteriorplug. In one embodiment, the opposing wings 908 spring to a natural orresting position that is generally perpendicular to the central shaft910 as they emerge from the cannula 914. Alternatively, the opposingwings 908 are pushed to an extended position using a pushing tool 918that is inserted through the cannula 914 and over the central shaft 910.

To clamp the plugs over the opening, the pushing tool 918 is pushed outfrom the cannula 914 and the thread 912 is pulled back through thecannula 914, drawing the first plug 902 toward the second plug 904 andclamping the annulus there between. In one embodiment, the first andsecond plugs include spikes or stabilizers 916 along their opposingwings that anchor into the annulus and further stabilize and clamp theplugs to the annulus. The cannula is removed and the extra length ofcentral shaft is removed. The thread is tied to hold the plugs in theclamped position. In addition, there can be a ratcheted mechanismbetween the central shaft 910 and the second plug 908 to hold the plugsin the clamped position as the second plug 908 slides or advances alongthe central shaft 910.

Referring to FIGS. 51-54, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a cover or cap-type plug is used in combination with aclamping mechanism such that the opening in the annulus is sealed withan exterior cap that is clamped to the annulus. In one embodiment, theclamping plug 920 includes a cap-type plug 922. The cap-type plug 922 issized to cover an opening 924 in an annulus 926, and will be disposed onthe exterior 928 of the annulus 924. In one embodiment, cap-type plug iscircular or disc shaped. A shaft 930 extends from the cap-type plug 922.Attached to the shaft 930 and spaced from the cap-type plug 922 is apair of anchor bars 932. The anchor bars 932 extend perpendicularly fromthe shaft 930 and are initially aligned with each other. In this alignedposition, the anchor bars pass 932 pass through the opening 924. Afterpassing through the opening 924, the cap-type plug 922 is rotated, whichinitially rotates the anchor bars 932 in opposite directions until thebars form an “X” (FIG. 52). In one embodiment, the anchor bars 932 areperpendicular to each other in the “X” position. In this position, theanchor bars 932 will not pass back through the opening 924.

In one embodiment, the anchor bars 932, following the initial rotationof the cap-type plug 922, lock in the “X” position. Continued rotationof the cap-type plug 922 draws the anchor plugs 932 toward the cap-typeplug 922, clamping the annulus 926 between the two. In one embodiment,the shaft 930 extends through the anchor bars 932 and into the interiorof the annulus 926. In one embodiment, the cap-type plug 922 includes akey hole or slot 936 to accept a tool (not shown) for rotating thecap-type plug 922.

Referring to FIGS. 55-57, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a plug and clamping mechanism 940 is used. The plug andclamping mechanism 940 includes a plug body 942 having an insert portion946 sized and shaped to fit into the opening 950 in the annulus 952. Theplug body 942 also includes an enlarged flange portion 948 that isattached to the insert portion 946 and that is of sufficient size to notpass through the opening. In one embodiment, the insert portion 946 iscylindrical and includes a hollow interior 944, and the flange portion948 is a circular flange. The flange portion 948 engages the exteriorsurface 954 of the annulus 952. At least one and preferable a pluralityof tangs 956 extend into the hollow interior 944.

The plug and clamping mechanism 940 also includes a clamping pin 958having a head 960 and a body 962. The body 962 extends through thehollow interior 944 and includes a plurality of grooves or nubs 964 thatengage the tangs 956 in the hollow interior 944. Therefore, as the body962 is advanced through the hollow interior 944, the tangs 956 in thehollow interior 944 engage the nubs 964 on the body 962 and hold or lockthe clamping pin 958 in the hollow interior 944. Disposed around thebody 962 of the clamping pin 958 between the head 960 and the plug body946 is a compression anchor 968. The compression anchor in an initialstate (FIG. 55) is sized to pass through the opening 950 in the annulus952. Once inside the annulus, the body 962 of the clamping pin 958 ispulled through the hollow interior 944, and the compression anchor 968is squeezed between the head 960 and the plug body 946. This squeezingforce moves the compression anchor 968 to an expanded state. In thisexpanded state, the compression anchor 968 is in contact with theinterior surface 972 of the annulus 952 and has a size that is greaterthan the opening 950 in the annulus 952. This secures the plug andclamping mechanism 940 in the annulus opening.

The compression anchor includes slots 970 on either side that facilitatethe bending of the sides and the expansion of the compression anchor968. In addition, these slots 970 facilitate the used of the compressionanchor in another embodiment of the plug and clamping mechanism asillustrated in FIGS. 58 and 59. In this embodiment, the plug body 972includes an insertion portion 974 with an enlarged flange portion 976attached to one end and a ribbed extension 980 attached to the otherend. Again, the flange portion 976 is sized and shaped to be larger thanthe opening 988 in the annulus 984 and to engage the exterior surface986 of the annulus 984. The ribbed extension 980 includes a plurality aparallel ribs 982 running along the length of the extension 980.

A pair of compressing arms 978 passes through slots 992 in the flangeportion and run along the body portion 974 and the extension 980. Eachcompressing arm 978 includes an end portion 981 that runs generallyparallel to the flange portion 976 and contacts the extension 980. Thecompression anchor 968 is disposed between the body portion 974 and theend portions 981 of the compressing arms such that the extension 980passes through the center of the compression anchor 968. The bodyportion 974, compressing arms 978 and compression anchor 968 are sizedto pass through the opening 988 in the annulus 984 (FIG. 58).

Once the compression anchor 968 passes completely through the opening988, the compressing arms 978 that extend through the flange portion 976are pulled out through the flange portion 976. This pushes the endportions 981 on the compression anchor 968, compressing and expandingthe compression fitting to a size greater than the opening 988. In thisstate, the compression anchor 968 is in contact with the interiorsurface 990 of the annulus 984 and the plug and clamping mechanism isanchored in the opening 988 of the annulus 984. The slots 970 in thecompression anchor 968 accommodate the compressing arms 978 as thecompression anchor 968 expands. Following expansion, the compressingarms 978 can be removed, for example by bending or rotating the arms tobreak a frangible connection and then removing the arms through theslots 992 in the flange portion 976. A second flowable plug material canalso be used in combination with this embodiment, for example, bypassing the flowable plug material through the slots 992 in the flangeportion 976 after removal of the compressing arms.

Referring to FIGS. 60-61, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 1000 includes an elongated stem or body 1006 havingone or more opposing pairs of flexible extensions 1002 on one end. Thesepairs have a natural extended position (FIG. 61) and include rollers orwheels 1010 attached to rods 1012 mounted to each flexible extension1002. An outer cap or seal 1011 is positioned on the opposite end of thebody 1006. The seal 1011 is larger than the annulus opening that isbeing repaired. The seal 1011 and extensions 1002 can be folded againstthe body 1006 so that the plug 1000 can be passed through a cannula1008. The cannula 1008 is passed through of brought adjacent to theannulus opening, and the plug is passes through the opening until theextensions pass into the interior of the annulus. The extensions 1002spring to their natural position and the wheels rolls along the interiorsurface of the annulus. The seal 1011 passes out from the cannula 1008,expands, contacts the exterior surface of the annulus and seals theopening. Suitable materials for the plug 1000 include flexible andresilient materials.

Referring to FIG. 62, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, cover or cap-type plugs are used in combination with aclamping mechanism and anchoring barbs such that the opening in theannulus is disposed or clamped between two cap-type plugs disposed onthe interior and exterior of the annulus opening. The clamp and plugdevice 1020 of this embodiment includes a pair of cap-type plugs 1022.In one embodiment, each cap-type plug 1022 is disc-shaped and includes acentral through hole 1024. The disc-shaped plug 1022 is of sufficientsize to cover the opening in the annulus that is to be repaired.Surrounding each central through hole 1024 and extending from the plug1022 is a collar 1026. At least one pair of barbs 1028 extend at anangle from each collar 1026. In one embodiment, each barb extends fromits collar at an angle greater than 0 degrees and less than 90 degreesfrom the associated plug. Extending through the collar and central holeof each plug is a shaft 1030 having a handle 1032 at one end thatfacilitates turning of the shaft 1030. Preferably, the shaft 1030 is athreaded shaft, and the collars 1026 include internal threads. Theinternal threads in the collars 1026 have the appropriate left and rightthread orientation so that rotation of the shaft handle 1032 draws thedisc-shaped plugs 1022 together. As the plugs 1022 are drawn together,the barbs 1028 anchor into the annulus.

Referring to FIGS. 63-65, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a plug 1040 is used to fill the opening in the annulus. Theplug 1040 is configured as a collapsible cage and includes a pair ofopposing ends 1042. Suitable materials for the collapsible cage include,but are not limited to titanium. In one embodiment, each opposing end1042 is configured as a disc having a central hole 1044 passingcompletely through the disc. In one embodiment, each opposing end 1042has a diameter 1045 that is less than the size of the annulus that is tobe repaired; therefore, each opposing end 1042 will pass through theopening in the annulus. In one embodiment, the diameter is about 6 mm.

A plurality of arms 1046 extend between the opposing ends 1042 and arefixedly secured to the opposing ends. The plurality of arms 1046 arearranged as opposing pairs, and in one embodiment, the plug 1040includes two opposing pairs of arms. Each arm is preferably a generallyflat arm having opposing thin edges 1047 and opposing flat faces 1049.Each arm 1046 is positioned so that one of the thin edges 1047 runsalong the outside of the plug 1040.

Along the length of each arm 1046 a spike 1048 extends out from theoutside thin edge. Opposite each spike across the arm a notch 1050extends inward from the inside thin edge. Preferably, the spike 1048 andnotch 1050 are located about midway along the length of each arm. Eachnotch 1050 provides a breaking or bending point for its arm as the plugis compressed or collapsed (FIG. 65). As each arm bends outward at thenotch when the plug is compressed, the spike 1048 forms a point, andthis point can penetrate the annulus to anchor the plug 1040 in theannulus opening.

In one embodiment, the plug 1040 is compressed by drawing the twoopposing ends 1042 together. In order to draw the two opposing endstogether, a first one of the opposing ends 1052 has a threaded centralhole 1054, and a second one of the opposing ends 1056 has a central holewithout threads 1058. A threaded rod or conventional threaded bolt (notshown) can be passed through the central hole without threads 1058 andinto the threaded central hole 1058 where it engages the threads. Afterthe plug 1040 is inserted into an annulus opening, the threaded rod isturned, drawing the opposing ends together (FIG. 65). At the same time,each arm 1046 bends outward, enlarging the size of the plug 1040 beyondthe diameter 1045 of the opposing ends. The arms engage the annulus andanchor the plug in the annulus opening.

In one embodiment, the plug 1040 also includes a second flowable plugmaterial 1060 (FIG. 64) or a second flexible plug that is disposedwithin the arms 1046 of the plug 1040. Suitable materials for theflowable plug 1060 include, but are not limited to, PCU. In oneembodiment, the flowable plug material 1060 fills approximately half thevolume within the arms and is initially in contact with one of theopposing ends 1042. The flowable plug material has an initialcylindrical shape with a central opening (not shown) to accommodate thethreaded rod. When the opposing ends 1042 are drawn together (FIG. 65),the flowable plug material 1060 is squeezed by both opposing ends andemerges from the plug 1040 to fill the interior space of the annulusopening. In one embodiment, additional flowable plug material can beinserted through the central holes 1044 in the opposing ends 1042following compression of the plug 1040 and removal of the threaded rod.

Referring to FIG. 66-69, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 1070 includes an expandable implant section 1072and a separate keeper and expander section 1074. The implant section1072 includes a neck 1075 having a central opening 1073 that passescompletely through the neck 1075. The neck is sized to fit within anannulus opening. Extending from the neck 1075 and formed from acontinuous band of material are a pair of expanding wings 1076. In oneembodiment as illustrated in FIG. 69, each expanding wing 1076 is formedas a pair of separate wing prongs 1088 having a slot 1089 disposedbetween them. This provides for more flexibility in the exposing wings1076, making expansion easier. Suitable materials for the implantsection 1072 and the expander section 1074 include, but are not limitedto, polyethylene, for example ultra high molecular weight polyethylene.

The keeper and expander section 1074 includes a head 1077 that is sizedto be larger than the annulus opening that is to be repaired. In oneembodiment, the head 1077 is a circular disc. Extending from the head1077 is a keeper portion 1078 having a plurality of tangs or ridges 1082running along its length. Extending from the keeper portion 1078 is anexpander portion 1080. In one embodiment, the keeper portion 1078 andexpander portion 1080 are both cylindrical, and the keeper portion 1078is a larger cylinder than the expander portion 1080. This creates ashoulder 1079 at the transition between the keeper portion 1078 and theexpander portion 1080.

An opening 1085 in an annulus 1083 is dilated, and the implant section1072 in inserted through the opening 1085 until the expanding wings 1076pass into the interior of the annulus 1083. The keeper and expanderportion 1074 is passed through the central opening 1073 of the neck1075, expanding the wings 1076 as described above. The expander portion1074 is advanced until the head 1077 engages the exterior surface 1084of the annulus, covering the opening, and the expanding wings 1076engage the interior surface 1086 of the annulus 1083. The opening issealed, and the plug 1070 is anchored in the opening 1085.

Referring to FIG. 67, the expander portion 1080 passes through theopening 1073 in the neck 1075 and a hole 1087 (FIG. 69) in the centralportion 1081 between the expanding wings 1076. The expander portion 1080is sized to pass completely through the hole 1087 in the central portion1081, and the shoulder 1079 engages the central portion. Advancing theexpander section 1074 further into the central opening 1073 moves thecentral portion 1081 in the direction of arrow J and the expanding wings1076 in the direction of arrow P. As the keeper portion 1078 advancesthrough the central opening 1073, the ridges 182 engage matingstructures inside the central opening 1073, securing the keeper andexpander section 1074 to the implant section 1072.

In an alternative embodiment as illustrated in FIG. 70, a plug is usedhaving an implant section 1090 with a neck 1092 sized to fit through theopening 2002 in the annulus 1096 and having a central hole 1094. Theexpanding wings 1098 extend from one end of the neck 1092, and anenlarged head 1093 is disposed on the other end of the neck 1092. Theenlarged head 1093 has a size that is greater than the opening 2002 inthe annulus 1096. Instead of the keeper and expander, a simple expanderis used that does not engage or anchor itself within the central hole.Once the opening 2002 is dilated, the implant section 1090 is passedthrough the opening 2002 until the enlarged head 1093 engages theexterior surface 1095 of the annulus 1096. Then an expander is insertedthrough the central hole 1094 to move the expanding wings 1098 intocontact with the interior surface 1097 of the annulus. The expander isremoved, and a hollow tube or cannula 2001 is inserted through thecentral hole 1094 to introduce a flowable plug material 2000 that fillsthe voids between the plug and the opening as well as voids within theinterior of the annulus.

Referring to FIGS. 71-75, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a flexible cover-type plug 2010 is used. The plug 2010 has asize and shape sufficient to cover an annulus opening, preferably fromthe interior of the annulus. Suitable shapes include, but are notlimited to, circular, oval and rectangular. This cover-type plug 2010 isconstructed from a sheet of flexible material 2011. The flexiblematerial can be constructed as a thin sheet of mesh material, a thinsheet of woven material, a thin sheet of non-woven material (for examplea thin sheet of biocompatible implant material similar to Tyvek® whichis commercially available from E.I. du Pont de Nemours and Company ofWilmington, Del. and combinations thereof). In general, the flexiblematerial is a plastic or polymer material.

Attached along the edge or perimeter of the flexible material 2011 is aresilient and flexible band 2012. The flexible band 2012 can be attachedto the flexible material using fasteners or adhesives. In oneembodiment, a small portion of the flexible material 2011 is folded overthe flexible band 2012, covering the flexible band 2012 in the flexiblematerial 2011. The overlapping flexible material 2011 is then sewntogether to secure the flexible band 2012 within the folded flexibleband 2012. The flexible band 2012 is formed in the desired shape of theplug 2010 and has sufficient resiliency to maintain the plug 2010 inthat shape and sufficient flexibility to be twisted and bent. In oneembodiment, the flexible band 2012 is titanium.

The plug 2010 has an expanded shape that is illustrated in FIG. 71. Inthis expanded shape, the plug 2010 is sized to cover an annulus opening.The plug 2010 will be located in the interior of the annulus in thisexpanded state; however, to insert the plug through the annulus openingto the annulus interior, the size of the plug 2010 is reduced by takingadvantage of the flexibility of the plug 2010. As show in FIG. 72,opposite ends 2013 of the plug are grip and rotated in oppositedirections to cross the flexible band 2012 in the middle. The two plugsections 2014 that are defined by the twisting action are folded ontoeach other about the point 2015 where the flexible band 2012 crossesitself. This results in a collapsed state (FIG. 73) for the plug 2010.Even in the collapsed state, the plug 2010 is flexible and can betwisted and rolled.

As illustrated in FIG. 74, the plug 2010 in its collapsed state isrolled around a cylindrical installation shaft 2016. The rolled plug2010 can slide along the length of the installation shaft 2016. In orderto hold the plug 2010 in the rolled position, a cylindrical sheath 2017is passed over the shaft 2016 and rolled plug 2010. The sheath 2017houses the rolled plug 2010 and has a size small enough to pass throughan annulus opening. In order to remove the rolled plug 2010 from thesheath 2017 and the installation shaft 2016, a pusher tool 2018 isprovided. The pusher tool 2018 includes a cylindrical body 2019 that isaligned coaxial with the sheath 2017 and installation shaft 2016.Attached to an end of the cylindrical body 2019 is a cylindrical head2020 having a circular opening 2010 with a diameter sufficient tofacilitate passage of the installation shaft 2016 into the head 2020.The head 2020 passes between the installation shaft 2016 and the sheath2017 until the leading edge 2022 of the head 2020 engages the rolledplug 2010, pushing the plug 2010 off of the installation shaft 2016.

As shown in FIG. 75, once the plug 2010 is inserted through the opening2024 in the annulus 2023, pushed from the installation shaft into theinterior of the annulus 2023 and allowed to unroll and to return to itsexpanded resting state, the plug is positioned 2010 to cover theinterior of the opening 2024. In one embodiment, the plug 2010 is thenanchored to the annulus using a plurality of sutures 2025 that are tiedto the plug 2010 at a plurality of locations, passed through the annulus2023 and tied on the exterior of the annulus 2023. One suture passesthrough the opening 2025. This suture is passed through an extra blockof plug material 2026 that is pushed into the opening 2024, and thesuture is tied to hold the plug material 2026 in the opening. As analternative to sutures or in combination with the sutures, darts or pinscan be used. These darts or pins are passed through the annulus andanchored in the flexible material of the plug.

Referring to FIG. 76, one embodiment of a pin 2030 for anchoring theflexible plug 2010 to the annulus 2023 is illustrated. The pin 2030 hasan enlarged disc-like head 2031 on its proximal end. In one embodiment,the head 2031 is of sufficient size to not pass through the opening 2024but to engage the exterior of the annulus and cover the opening. The pin2030 is sized, with the exception of the head, to pass through theannulus opening. The distal end of the pin 2030 includes a point 2032that can pierce the flexible material of the flexible plug 2010. Aplurality of wedge-shaped portions 2033 run along the length of the pin2030. These wedge-shaped portions 2033 allow the pin to pass through theflexible material and define a plurality of shoulders 2034 runningaround the pin 2030 that can engage and hold the flexible material.

Referring to FIGS. 77-78, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a plug 2040 is provided that has a head portion 2041 sizedto be larger than the opening 2042 in the annulus 2043 between twovertebral bodies 2045. The head portion 2041 is formed with a curvaturethat compliments and mates with the curvature of the exterior surface2044 of the annulus 2043. A plurality of barbs 2053 are attached to andextend from the head portion 2041. The plug 2040 also includes a taperedbody 2046 attached to and extending from the head 2041. The tapered body2046 extends a sufficient distance from the head so that it passescompletely through the opening 2042 in the annulus 2043. The taperedbody is larger or wider adjacent the head and narrows as it extends fromthe head.

A central cylindrical shaft 2047 extends completely through the head2041 and the tapered body 2046. A push rod 2048 having a disc-shaped end2050 and a rod portion 2049 attached to and extending from the end 2050is disposed in the cylindrical shaft 2047. The head portion 2041includes a pocket 2052 sized and shaped to accommodate the disc-shapedend 2050 of the push rod 2048. Initially, the rod portion 2049 is onlypartially inserted through the cylindrical shaft 2047 starting from thehead portion 2041 of the plug 2040 (FIG. 77). In one embodiment, thelength of the cylindrical shaft 2047 into which the rot portion 2049does not extend if filled with a flowable plug material 2051.

In use, the tapered body 2046 is inserted into the opening 2042 in theannulus 2043 and the barbs 2053 extend into the annulus 2043 until thehead portion 2041 contacts the exterior surface 2044 of the annulus2043. The push rod 2048 is advanced in the direction of arrow K untilthe end 2050 is located within the pocket 2053 of the head portion 2041(FIG. 78). The rod portion 2049 pushes the flowable plug material 2051from the cylindrical shaft 2047. The flowable plug material plugs theinterior of the opening 2042 and anchors the plug 2040 from beingexpelled out from the opening.

Referring to FIGS. 79-80, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a cover-type plug 2065 is used to cover the opening 2063 inthe annulus 2062 at the interior surface of the annulus. In oneembodiment, the plug 2065 is a deployable sheath that can be constructedfrom metal such as titanium, a polymer or combinations thereof. In oneembodiment, the plug is a polymer covered metal. The plug 2065 has anatural or resting shape that is generally circular and is sufficientlyflexible and resilient that it can be folded or wound into a smallerspiral shape.

In order to deploy the plug 2065, a hole 2061 is drilled through eitherthe superior vertebral body 2060 or the inferior vertebral body 2064into the interior of the disc 2066 without touching the annulus 2062.The plug 2065 is rolled or folded to a size small enough to pass throughthe hole 2061 and is introduced through the hole 2061 into the interiorof the disc 2066. The plug 2065 is allowed to return to its restingposition, where it unfolds or unrolls and contacts the interior surfaceof the annulus 2062. This covers the annulus opening 2063 and internaldisc pressure holds the plug 2065 against the annulus 2062. In oneembodiment, a flowable or formable plug material can also be used tofill the opening 2063 from the exterior of the opening. The hole 2061 isclosed, for example, using a small screw made of a resorbable material.

Referring to FIGS. 81-82, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a cover-type plug 2070 is used to cover and close theopening 2073 in the annulus 2074. The plug 2070 is attached to theexterior surface 2075 of the annulus 2074. Suitable materials includemetals such as titanium and polymers such as PCU. The plug 2070 isprovided with a curvature that accommodates the curvature of theexterior surface 2075 of the annulus 2074. The plug 2070 includes aplurality of barbs 2072. In one embodiment, the plug 2070 includes fourbarbs 2072 arranged as opposing pairs and formed from cut-outs 2077 inthe body of the plug 2070. The plug 2070 is placed over the opening, andthe barbs 2072 are pushed into the annulus 2074. In one embodiment, eachbarb 2072 extends from the plug 2070 at an angle 2076 that is less thanabout 90°. In addition, all of the barbs 2072 extend from the plug 2070toward a central region 2078 of the plug. When the plug 2070 is attachedto the annulus 2074 such that a resultant stretching force exists aroundthe circumference of the annulus between the annulus and the plug asindicated by arrow L, this stretching force drives the barbs, which facein directions that oppose this force, into the annulus. This works tosecure or hold the plug to the annulus.

Referring to FIGS. 83-84, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 2080 is formed as either a living hinge or amechanical hinge. As illustrated, the plug 2080 is formed of a bar orblock of material 2081 that has a resting or natural position that isflat. Suitable materials for the block of material include, but are notlimited to, metals such as titanium and polymers, for example PCU. Theblock of material is bent into a “U” shape and placed in the interior2082 of a cannula 2083. The interior is sized to be smaller than theopening 2084 of the annulus 2086 that is to be repaired. The cannulaholds the block of material in the “U” shape. A plurality of pointedteeth 2085 extends from the block of material.

The plug 2080 is advanced from the cannula 2083 in the direction ofarrow M until the plug exits the cannula and passes through the opening2084 in the annulus 2086. The portion of the plug containing the teeth2085 passes into the interior 2087 of the disc. A hinge portion 2088 ofthe plug 2080 remains in the opening 2084. The opposing legs 2089 of theplug 2080 are biased away from each other as indicated by arrow N. Thisbiasing force drives the teeth 2085 into the interior surface of theannulus and forces the hinge portion 2088 into the walls of the opening2084. This anchors the plug 2080 in the opening. A second flowable plugmaterial can also be used in conjunction with the plug 2080 to fill ingaps between the plug 2080 and the annulus 2086. In another embodiment,the hinge portion contains a mechanical hinge, for example a springloaded hinge, that biases the opposing legs 2089 of the plug 2080 awayfrom each other. Suitable mechanical hinges are known and available inthe art.

Referring to FIGS. 85-88, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 2090 includes an integrated anchoring mechanismthat is activated after the plug is inserted into the opening 2091 inthe annulus 2092 that is being repaired. The plug 2090 includes aplurality of independent and separate segmented arms 2093. Eachsegmented arm 2093 includes a plurality of segments. In one embodiment,this plurality of segments includes a primary segment 2094, a firstintermediate segment 2095 attached to one end of the primary segment, asecond intermediate segment 2096 attached to the first intermediatesegment and an end segment 2097 attached to the second intermediatesegment. The first intermediate segment 2095 is disposed between theprimary segment and the second intermediate segment, and the secondintermediate segment 2096 is disposed between the first intermediatesegment and the end segment. In one embodiment, the adjacent segmentsoverlap, and a pivot pin 2099 passes through this overlapped section sothat the adjacent segments are attached at a pivot point or joint.Alternatively, all of the segments are formed as a single piece ofmaterial with a notch or bend formed in the material at the transitionbetween each segment. Therefore, the single piece of material will bendat these points to define the various segments. Suitable materials forthe segments and pivot pins include, but are not limited to, metals suchas titanium and plastics or polymers such as PCU.

Initially, the primary segment 2094 and first and second intermediatesegments are arranged in a first straight line. The end segment 2097 islocated along a second line that is separate from and parallel to thefirst line. In one embodiment, the end segment touches at least one ofthe first and second intermediate segments along their length. In orderto provide for this initial off set alignment between the first andsegment intermediate segments and the end segment, the end segment 2097has an “L” shape. The second intermediate segment, on the end that ispivotally attached to the end segment, has a rounded edge 2098. Thisfacilitates passage of the plug 2090 through the opening 2091 in theannulus 2092.

Each primary segment 2094 includes a distal end that is pivotallyattached to the first intermediate segment 2095. The proximal end 3000of the primary segment 2094 opposite the distal end is enlarged andincludes a hook portion 3002. The hook portion 3002 engages the exteriorsurface of the annulus adjacent the opening. The length 3004 of theprimary segment from approximately the hook portion 3002 to the pivotpin 2099 between the primary segment and the first intermediate segment2095 is varied depending on the thickness of the annulus and is selectedsuch that the primary segment will pass completely through the openinguntil the pivot pin 2099 emerges in the interior of the disc.

In one embodiment, the plurality of segmented arms is arranged around acommon axis to form the general shape of a cylindrical plug with anenlarged head. Cross members (not shown) can be provided between theprimary segments of each segmented arm to hold the plurality ofsegmented arms together. All of the proximal ends 3000 of the segmentedarms 2093 yield an enlarged head having an overall diameter 3006 that islarger than the opening 2091 in the annulus 2092. In one embodiment, theplug 2090 includes an even number of segmented arms arranged as opposingpairs. Preferably, this even number of segmented arms is four arms.

The plug 2090 also includes a threaded set screw 3008 that runs throughthe center of the cylindrical shape created by the plurality ofsegmented arms along and concentric with the common axis of thesegmented arms. Suitable materials for the set screw include, but arenot limited to, metals such as titanium. The set screw has an enlargedhead 3010 at its proximal end and is threaded 3014 on its distal end.The enlarged head 3010 includes a slot 3012 for accepting a tool such asa flathead screwdriver for turning the set screw 3008. The enlarged end3000 of each segmented arm includes a curved pocket 3016 to accept theenlarged head 3010 of the set screw. The curved pocket allows the setscrew to turn while holding the set screw within the plug 2090. Thethreaded distal end 3014 of the set screw is in contact with each endsegment 2097 of the segmented arms. Each end segment includes a notch3018 to accommodate the threaded distal end 3014. The notch can havecomplementary threads or the end segment can be formed of a materialthat is sufficiently soft to be gripped by the threads.

In the initial state as illustrated in FIG. 85, the plug is insertedthrough the opening 2091 in the annulus 2092 (FIG. 87). As the set screwis turned in accordance with either a left-hand or right-hand thread,the relative rotational motion between the threaded distal end 3014 andthe notch 3018 draws the end segment 2097 in the direction of arrow Nparallel to the primary segment toward the distal end of the set screw(FIG. 86). All of the segments begin to rotate relative to each otherabout the pivot pins 2099. This forces the first and second intermediatesegments out of alignment with the primary segment and toward a positionthat is perpendicular to the primary segment. The first and secondintermediate segments contact the interior surface of the annulus,pulling the enlarged ends 3000 toward the exterior surface of theannulus and forcing the hook portions 3002 into the annulus. Thisanchors and holds the plug 2090 in the opening 2091. As viewed from theinside of the disc in FIG. 88, the segmented arm 2093 expands but doesnot exceed the thickness 3020 of the annulus.

Referring to FIGS. 89-90, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a cover-type plug 3050 is used that is provided in the formof a ribbon of material that is wrapped around the exterior surface ofthe annulus 3052. Suitable materials for the plug include, but are notlimited to, polymers including polytetrafluoroethylene (PTFE), which iscommercially available under the tradename Teflon from E.I. du Pont deNemours and Company of Wilmington, Del. The plug 3050 is provided in thelength that is at least as long as the outer circumference of theannulus 3052 and a width that is sufficient to cover the opening 3054 inthe annulus.

In order to install the plug 3050, the plug 3050 is attached to the endof a flexible hook 3056 that has a natural position that is curved. Inone embodiment, the flexible hook is a nitinol (nickel titanium) hook.The flexible hook and attached plug are placed in a cannula 3058 orother suitable insertion tube (FIG. 90). In this retracted state, thecannula is placed adjacent the annulus, and the flexible hook and plugare extended from the cannula. Given the natural curved position of theflexible hook, the flexible hook and plug extend around the exteriorsurface of the annulus. The flexible plug is then attached to theexterior surface of the annulus at a given point 3060 using any suitableattachment mechanism, for example sutures. The flexible hook is thenretracted into the cannula, leaving the plug 3050 extending around theannulus. The plug extends sufficiently around the annulus to completelycover the opening 3054 and in one embodiment extends completely aroundthe annulus. The plug is cut or trimmed after it has been extended asufficient distance around the annulus, and the plug is attached to theannulus at this second position after it is extended around the exteriorof the annulus. The flexible hook is then retracted inside the annulus.In one embodiment, the opening is also filled with a flowable plugmaterial that is placed in the opening before the plug 3050 is extendedaround the annulus.

Referring to FIGS. 91-92, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a cover-type plug 3070 is provided. Suitable materials forthe plug 3070 include, but are not limited to, metals such as titaniumand polymers such as PCU. The plug 3070 includes a first outer component3072 and a second inner component 3074. In one embodiment, the first andsecond components are generally circular, although the components can beprovided in any desired geometric shape. The first component 3072includes a slot 3078 sized to hold the second component 3074. The secondcomponent 3074 can be completely stored within the slot 3078.

The first and second components are both rotatable about a commoneccentric shaft 3076 that passes completely through the first and secondcomponents. Therefore, the second component 3074 rotates around theshaft 3076 into and out of the slot 3078. The second component 3074 ismoved from a position where it is completely contained within the slot3078 and the plug 3070 has its minimum size to a position where it isoutside (as illustrated) the slot 3078 opposite its position within theslot and the plug 3070 achieves is maximum size 3084 or height. Aplurality of pins 3082 are inserted through holes 3083 in both the firstand second components that align when the second component 3074 isrotated to the position yielding the maximum plug size. This locks thatplug in this position.

The plug 3070 is used to cover openings in the annulus from either theinterior or exterior of the annulus. In one embodiment, the plug ispassed through the annulus opening with the second component locatedwithin the slot 3078. The second component is then rotated to themaximum plug size position and locked in that position. Therefore, theplug 3070 covers the entire annulus opening. The plug 3070 also includesat least one barb 3080 that is attached to or formed integral with thefirst component. The barb 3080 anchors the plug 3070 to the annulusadjacent the opening. In one embodiment, the plug 3070 is used incombination with a flexible or flowable plug material that is used tofill the annulus opening.

Referring to FIGS. 93-99, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. Referringto FIGS. 93-94, the plug in this embodiment utilizes an anchor plate3090. The anchor plate 3090 is part of a plug assembly and is passedthrough the annulus opening to the interior of the disc and makescontact with the interior surface of the annulus to anchor the plugassembly to the annulus. The anchor plate 3090 is constructed from afront plate 3094 having a front plate opening 3098 and a back plate 3092having a back plate opening 3096. In an initial or rest position asillustrated, the front plate 3094 is aligned with the back plate 3092,while the front plate opening 3098 is not aligned with the back plateopening 3096. The two openings are offset, and there is a biasing member(not shown) disposed between the two plates that biases the platestoward the rest position. In one embodiment, the two openings arecircular. Alternatively, as illustrated in FIG. 95, the front plateopening 3099 and the back plate opening 3097 have an elongated shape.The shape of the openings is selected based upon the shape of the pluginsert that is being used in conjunction with the anchor plate.

Referring to FIGS. 96 and 97, the plug insert portion 4002 of the plugincludes a tapered portion 4003, an anchor plate portion 4004 extendingback from the tapered portion, a plug portion 4006 extending from theanchor plate portion and an enlarged head portion 4008 extending fromthe plug portion. The tapered portion 4003 is shaped to pass through theopenings in the anchor plate 3090 and to move the first and secondplates from their rest position toward a position where the openings arealigned. A ridge or edge 2011 between the tapered portion and the anchorplate portion 4004 contacts with a side 4010 of the back plate 3092after the tapered portion passes completely through the anchor plate3090. When this ridge 2011 is circular and extends completely around theplug insert portion, circular openings are used. When the ridge extendsout from the plug insert portion in two opposite directions (FIG. 97),elongated openings are used. The anchor plate portion is preferablycylindrical and has a diameter equal to the diameter or width of theopenings. Therefore, as the tapered portion passes through the openings,the anchor plate portion engages the openings.

The plug portion is sized to substantially fill the opening 4012 in theannulus 4009. The enlarged head portion 4008 is larger than that opening4012 and engages the exterior surface of the annulus 4009. Initially,the anchor plate 3090 is passed through the opening, and the openings inthe anchor plate are aligned with the opening in the annulus. The pluginsert portion is passed through the opening in the annulus and theopenings in the anchor plate until the tapered portion is passedcompletely through the anchor plate openings. For elongated anchor plateopenings, the plug insert portion is then rotated 90° so that thetapered portion engages the side of the back plate. The anchor plate isin contact with the interior surface of the annulus, and the enlargedhead portion is in contact with the exterior surface of the annulus,anchoring the plug in the opening.

In an alternative embodiment as illustrated in FIG. 98-99, an alternateanchor plate 4019 is used in which the back plate 4022 having a backplate opening 4024 and the front plate 4020 having a front plate openingmeet along a sloped face 4028. Each plate does not extend across theentire width of the anchor plate 4019. In addition, each plate includesa barb 4030 on one end, and this barb engages the annulus 4009 when theplug assembly is inserted into the opening 4012 (FIG. 99).

Referring to FIGS. 100-101, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 4050 is formed from a layer of collagen 4052attached to a mesh 4054. Suitable materials for the mesh include, butare not limited to, decellularised extracelluar matrices (ECM) and smallintestine submucosa (SIS) mesh, which is commercially available fromCook Medical of Bloomington, Ind. Alternatively, the plug can be formedof a synthetic polymer. The mesh and collagen material is folded andstack accordion style into a plurality of layers. The number of layersand the size of each fold is selected based upon the size of the opening4062 in the annulus that is to be repaired.

Cells 4058 are injected between each layer. In one embodiment, a mixtureof cells and growth factors (GFs) is injected between each layer. Asillustrated, the cells 4058 are injected between opposing mesh 4056layers. Alternatively, the cells can be provided between opposingcollagen 4052 layers or between both opposing mesh and opposing collagenlayers. In order to facilitate the folding of the layers and to hold thefolded plug in the folded position, a guide fiber 4056 is anchored tothe first folded layer, passed through each of the folded layers andsecured or tied to the final folded layer. The plug 4050 is theninserted into the annulus opening 4062 such that the folds run from theinterior of the opening to the exterior of the opening. In order tosecure the plug in the opening, a glue or adhesive 4064 is applied overthe opening and the plug on the exterior surface of the annulus 4060.

Referring to FIG. 102, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a plug 4070 is provided having a narrow end 4071 and a wideend 4073. In three dimensions, the plug is substantially egg-shaped.Suitable materials for the plug include, but are not limited to,polymers and plastics such as PCU. The plug also includes a plurality ofcurved spines that extend from the sides and narrow end 4071 of theplug. Suitable materials for the spines include, but are not limited to,polymers, plastics and metals, for example titanium.

In one embodiment, all of the spines curve around the plug in the samedirection. Alternatively, the spines curve around the plug in twodifferent directions. The plug is inserted through an annulus openingnarrow end first until the wide end is located substantially even withthe exterior surface of the annulus. The spines extend into the interiorwalls of the opening, preventing the plug from being drawn farther intoor being expelled from the opening. In one embodiment, the spines areretractable or spring loaded and extend into the sides of the openingafter the plug has been inserted into the opening. In one embodiment,the plug is used in combination with a flowable plug material to fillthe gaps between the plug and the opening in the annulus.

Referring to FIGS. 103-104, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 4080 is arranged as a “pop-rivet” type plug.Suitable materials for this plug 4080 include, but are not limited to,metals such as titanium. The plug 4080 includes a rivet portion 4083sized to pass through an opening 4087 in an annulus 4088. One end of therivet portion 4083 is formed as an enlarged head 4084 that is size largeenough to not pass through the annulus opening 4087 but to engage theexterior surface of the annulus 4088. The opposite end of the rivetportion 4083 has an opening that passes completely through the rivetportion. Extending through this opening is a shaft 4085 that extendssufficiently through the enlarged head to provide sufficient grippingsurface for a tool that will compress the plug 4080. One end of theshaft 4085 includes a ball that is sized larger than the opening in therivet portion. The ball is still small enough to pass through theannulus opening.

The ball and rivet portion is passed completely through the openinguntil the enlarged head touches the annulus. A tool is used to grip theshaft. The tool also engages the enlarged head. The tool pushed on theenlarged head and draws the shaft through the rivet portion. This movesthe ball toward the enlarged head, compressing the rivet portion. Therivet portion is deformed into a compressed portion 4086 on the interiorof the disc that is larger than the annulus opening. This compressedportion is in contact with the interior surface of the annulus. Havingachieved the desired compression, the tool clips that shaft at a pointthat is substantially even with the enlarged head. The opening is thussealed and the plug is secured in the annulus opening. In oneembodiment, this plug is used in combination with a flowable plugmaterial that fills gaps and voids between the plug and the annulusopening.

Referring to FIGS. 105-107, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, the plug 4090 is formed as an elongated box or cylinderhaving an initial width 4095 that is less than the size of the annulusopening. The leading end of the plug includes a ball or portion of aball to aid in inserting the plug into the opening. The plug 4090 alsoincludes a central cavity 4093, and an inserting pusher 4094 is insertedinto the cavity. The pusher 4094 is used to insert the plug into theannulus opening. Having inserted the plug into the annulus opening, thepusher is removed from the cavity 4093. A first spreader 4096 that issized larger than the cavity is passed through the cavity to expand theplug. The first spreader is removed, and a second, larger spreader 4097is passed through the cavity. This expands the plug 4090 to a final size4098 that is larger than the annulus opening. This plug can also be usedin combination with a flowable plug material.

Referring to FIGS. 108-113, another embodiment of the soft tissue repairsystem of the present invention using a plug is illustrated. In thisembodiment, a cannula or insertion tool 5001 is passed through theopening 5000 in the annulus 5002. A pair of bent wires or needles 5004having a hooked-shaped natural position is passed out the end of thecannula 5001 into the interior of the disc. The wires 5004 continue toextend out from the cannula 5001, through the annulus 5002 adjacent theopening to the exterior of the annulus. A suture clamp and grip tool5006 is passed over the cannula 5001 (FIG. 111), and the wires 5004 areextended until they are anchored or embedded in the clamp and grip tool5006. Thread or suture material 5008 attached to the wires emerges fromthe cannula on the interior of the disc.

The clamp and grip tool 5006 is then pulled back from the cannula 5001(FIG. 112), drawing additional sutures 5008 and the plug 5010 from thecannula. The cannula 5001 is then pulled out from the opening (FIG.113), leaving the plug 5010 in the opening and exposing additionalsutures 5011 attached to the other end of the plug 5010 on the exteriorof the annulus. The sutures are then tied together, and the excess iscut. Suitable materials for the plug 5010 include flexible plugmaterials including polymers or plastics such as PCU.

While it is apparent that the illustrative embodiments of the inventiondisclosed herein fulfill the objectives of the present invention, it isappreciated that numerous modifications and other embodiments may bedevised by those skilled in the art. Additionally, feature(s) and/orelement(s) from any embodiment may be used singly or in combination withother embodiment(s) and steps or elements from methods in accordancewith the present invention can be executed or performed in any suitableorder. Therefore, it will be understood that the appended claims areintended to cover all such modifications and embodiments, which wouldcome within the spirit and scope of the present invention.

What is claimed is:
 1. A soft tissue repair system for an intervertebraldisc having an annulus and a nucleus pulposus, the system comprising: afirst plug configured to close an opening that passes through theannulus from an exterior surface of the annulus to an interior surfaceof the annulus, the first plug comprising a collapsible cage having apair of opposing ends and a plurality of arms extending between theopposing ends and fixedly secured thereto, the collapsible cageconfigured to collapse and to expand to fill the opening in the annulus;and a second plug separate from the first plug and configured to closethe opening, the second plug comprising a flowable plug material havingan initial cylindrical shape with a central through-hole, the secondplug being disposed within the opposing ends and the plurality of armsof the collapsible cage, the second plug emerging from the collapsiblecage as it is collapsed, wherein each arm includes a spike disposedmid-way between the opposing ends on a top surface of the arm and eacharm includes a notch disposed underneath the spike on a bottom surfacethe arm.
 2. The soft tissue repair system of claim 1, wherein each spikeextending outward from the collapsible cage, each spike configured topenetrate the annulus when the collapsible cage is collapsed.
 3. Thesoft tissue repair system of claim 1, wherein each of the pair ofopposing ends is configured as a disc.
 4. The soft tissue repair systemof claim 1, wherein each of the pair of opposing ends includes a centralhole passing completely therethrough.
 5. The soft tissue repair systemof claim 1, wherein each of the pair of opposing ends has a diameterthat is less than the size of the annulus that is to be repaired.
 6. Thesoft tissue repair system of claim 1, wherein the plurality of arms isarranged as opposing pairs.
 7. The soft tissue repair system of claim 1,wherein the plurality of arms includes at least one having a generallyflat arm with opposing thin edges and opposing flat faces.
 8. The softtissue repair system of claim 7, wherein the plurality of arms ispositioned so that one of the thin edges runs along the outside of thefirst plug.
 9. The soft tissue repair system of claim 1, wherein thefirst plug is compressed by drawing the two opposing ends together. 10.The soft tissue repair system of claim 1, wherein the second plug isconfigured to fill an interior space of the opening of the annulus whenthe collapsible cage is collapsed.
 11. The soft tissue repair system ofclaim 1, wherein the second plug is made of polycarbonate urethane(PCU).
 12. A soft tissue repair system for an intervertebral disc havingan annulus and a nucleus pulposus, the system comprising: a plugconfigured to close an opening that passes through the annulus from anexterior surface of the annulus to an interior surface of the annulus,the plug comprising a collapsible cage having a pair of opposing endsthat define a longitudinal axis and a plurality of arms extendingbetween the opposing ends along the direction of the longitudinal axisand fixedly secured thereto, the collapsible cage configured to collapsealong the longitudinal axis and for the arms to expand laterally to thelongitudinal axis to fill the opening in the annulus; wherein each armof the plurality of arms includes a spike disposed along its length andextending laterally from the longitudinal axis on a top surface of thearm, each spike configured to penetrate the annulus when the collapsiblecage is collapsed, and wherein each arm includes a notch disposedunderneath the spike on a bottom surface the arm.
 13. The soft tissuerepair system of claim 12, wherein each of the pair of opposing ends isconfigured as a disc.
 14. The soft tissue repair system of claim 12,wherein each of the pair of opposing ends includes a central holepassing completely therethrough.
 15. The soft tissue repair system ofclaim 12, wherein each of the pair of opposing ends has a diameter thatis less than the size of the annulus that is to be repaired.
 16. Thesoft tissue repair system of claim 12, wherein the plurality of arms isarranged as opposing pairs.
 17. The soft tissue repair system of claim12, wherein the plurality of arms includes at least one having agenerally flat arm with opposing thin edges and opposing flat faces. 18.The soft tissue repair system of claim 17, wherein the plurality of armsis positioned so that one of the thin edges runs along the outside ofthe first plug.
 19. The soft tissue repair system of claim 12, whereinthe first plug is compressed by drawing the two opposing ends together.